BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1890898 · Received October 29, 2010

    Report

    Report Number
    2135225-2010-00071
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    March 18, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MERZ AESTHETICS, INC (FORMERLY BIOFORM MEDICAL, INC)
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: CATALOG: 8005P10, LOT: 1013660, EXPIRATION DATE: 06/30/2012. ADDITIONAL IMPLANT DATE: 03/18/2010. ADDITIONAL DEVICE MANUFACTURE DATE: 06/01/2009. (B)(4). THIS EVENT WAS REPORTED IN THE LINE LISTING OF THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR (B)(4), SUBMITTED TO THE FDA ON 09/30/2010. SINCE THE ADVERSE EVENT REQUIRED CATHETERIZATION TO CORRECT URINARY RETENTION, THIS EVENT WAS DETERMINED TO BE A REPORTABLE EVENT. THE DEVICE HISTORY RECORDS FOR COAPTITE LOTS 1012957 AND 1013660 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED FOR EITHER LOT.

    Description of Event or Problem · 1

    COAPTITE POST APPROVAL STUDY. A PATIENT (B)(6), WAS ENROLLED IN THE POST-APPROVAL COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED TWICE; THE FIRST TIME ON (B)(6) 2009 WITH 2.0ML COAPTITE, AND THE SECOND TIME ON (B)(6) 2010 WITH 2.0ML COAPTITE. THERE WERE NO REPORTED AES AFTER THE (B)(6) INJECTION. THE PT NOTES INDICATE THAT THE PT WAS UNABLE TO VOID AFTER THE MARCH COAPTITE TREATMENT. A #10F FOLEY CATHETER WAS PLACED ON (B)(6) 2010. IT WAS REMOVED THE FOLLOWING DAY, AND THE PT WAS ABLE TO VOID SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC (FORMERLY BIOFORM MEDICAL, INC) 1012957

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention